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Completed

NCT Number: NCT02854566

Periprosthetic Fractures of the Femur Treated by Osteosynthesis

Observational retrospective study on 36 consecutive patients having had surgery for a periprosthetic fracture of the femur between 2010 and 2015.

The goal of the study is to test whether osteosynthesis was a secure choice at a certain age and with any type of Vancouver fracture.

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Key information

Conditions

Periprosthetic Fracture of the Femur

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients having had surgery between 2010 and 2015 within the CHU Brugmann hospital for a periprosthetic fracture of the femur (osteosynthesis).

Exclusion criteria

  • Death during surgery.

Treatment and study plan

osteosynthesis

Device

Fracture reduction and fixation with screws/plates/cables (standard of care)

Primary outcomes

  1. Age

    Time frame: Up to 2-3 days before surgery (pre-surgery radiography)

    Demographic data

  2. Sex

    Time frame: Up to 2-3 days before surgery (pre-surgery radiography)

    Demographic data

  3. Body Mass Index

    Time frame: Up to 2-3 days before surgery (pre-surgery radiography)

    Demographic data

  4. Prosthesis type

    Time frame: Up to 2-3 days before surgery (pre-surgery radiography)

    PTH (total hip prosthesis) or BHP (bipolar hip prosthesis)

  5. Type of fracture

    Time frame: Up to 2-3 days before surgery (pre-surgery radiography)

    Type of fracture according to the Vancouver International Classification

  6. Femoral component

    Time frame: Up to 2-3 days before surgery (pre-surgery radiography)

    Need for cement within the femur or not

  7. Time between 1st surgery and fracture

    Time frame: Up to 2-3 days before surgery (pre-surgery radiography)

    Time between 1st surgery and fracture

  8. Fracture healing

    Time frame: 10 months after surgery

    Healing status of the fracture (healed/not healed)

  9. Mortality rate

    Time frame: 10 months after surgery

    Mortality rate (any causes)

  10. Complications rate

    Time frame: 10 months after surgery

    Total complications rate (local + systemic + implant)

  11. ASA score

    Time frame: During surgery (up to 2 hours)

    ASA score

  12. Blood loss

    Time frame: During surgery (up to 2 hours)

    Blood loss during surgery

Secondary outcomes

  1. Laterality

    Time frame: Up to 2-3 days before surgery (pre-surgery radiography)

    Prosthesis on the right or on the left side

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2016
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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